FDA Denies Approval for Stroke Drug
The FDA has denied approval for a Grace Therapeutics drug designed to treat strokes caused by ruptured brain aneurysms. The agency cited concerns regarding the chemistry, manufacturing, and controls of the injectable medication produced by the New Jersey-based company. Grace Therapeutics plans to resolve the identified issues and resubmit its application for the treatment.
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Sources · 7 independent
NBC News Radio
“The FDA is denying approval for a grace therapeutics drug intended to treat a rare but often deadly type of stroke. The agency says it has issues with the chemistry, manufacturing, and controls”
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